This program is approved by New Jersey Department of Education (DOE) and Department of Labor and Workforce Development (DOL). Funding Option is available to qualified NJ Resident students, contact us to check on requirements.

A Drug Safety-Pharmacovigilance Data and Safety Monitoring and report submissions to Authorities. Responsible for the monitoring, data collection, analysis and reporting of drug safety information for compliance with drug safety regulations per international markets.
Data Management.

Our Programs are delivered in 2 Different ways for convenience of student:

• Self-Paced Individual Program (SIP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions.
• Self-Paced Blended Program (SBP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. The student participates in 7 days Post Training Assistance program for Resume preparation.

  • Admission Requirements:

    Recommended: A Bachelor or Master’s degree in medicine, Nursing (RN), Pharm D, Public Health, Pharmaceutical and Industrial Chemistry, Industrial Pharmacy, Industrial Chemistry.

  • Institutional Scholarship / Promotion:

    Institutional Scholarship / Promotion is available for selected on tuition. We review your educational background, certifications, and prior experiences (if applicable), to evaluate your eligibility. The qualified student will be provided with the promo code for scholarship on Tuition.
    Please Email your resume to Human Resources qpdc@qtech-solutions.cato check on your eligibility. We will contact you. Qtech’s objective is to provide you the right career pathway and advancement required to meet your career goals.

  • Learning Outcomes:
    The Benefit Student Gains
    • Upgrading the Knowledge required.
    • Better Resume Placement for promising jobs.
    • Low Investment, high learnings
    • Learn from Anywhere, Anytime at your pace.
    • Job and Title Based Tasks as followed and Practiced in industry
    • Applying Concept into Real-time (Policies, governance and tools)
    • Work on Role Based Tasks followed and Practiced in industry
    • Mocks and Narratives for Client Discussions
    • Readiness to work with limited support
  • Career Pathways

    Our objective is to help students to meet the following career pathways. Typical Drug Safety / Pharmacovigilance Associate (DSA) Job Titles the candidates can apply after this training program are

DRUG SAFETY MANAGER / PHARMACOVIGILANCE SPECIALIST JOB TITLES
  • Drug Safety Associates
  • Pharmacovigilance Associate
  • Case Processor
  • Medical Record Extractor
  • Drug Safety Coordinator
  • Patient Safety Manager
  • Medical Reviewer
  • Local Safety Manager

Designed by industry experts for students and young professionals. The training program provides in depth knowledge of roles and responsibilities of Drug Safety / Pharmacovigilance Specialist including theoretical aspect of the field and exposure to variety exercises based on industry requirements.

DRUG SAFETY-PHARMACOVIGILANCE DATA MANAGEMENT
DRUG SAFETY – PHARMACOVIGILANCE ASSOCIATE TOPICS:

1. Introduction to Clinical Research

2. Drug Development Process

3. Introduction to Drug Safety /

Pharmacovigilance

4. Role of DSA / PVA (Trials)

5. Introduction to Adverse Events

6. ICH-Good Clinical Practice Guidelines

7. Drug Safety Regulation and Guidelines

8. Overview of the Clinical Trial Protocol

9. Characteristics of a Case

10. Sources of Individual Case Reports

11. Drug Safety Data Extraction and

Pre-Processing

12. SOP Development

13. Communication with Cross

Functional Team

14. Understanding 21 CFR Part 11

and HIPAA

15. Basic of Coding in Drug Safety

16. Case Follow up approaches and handling of Cases

17. Clinical Trial Safety Surveillance

18. Phase IV Trials and Pharmacovigilance 19. Case Narratives

20. SAE Reconciliation

21. Drug Safety Database and Software

22. Special Scenarios

ADVANCED DRUG SAFETY TOPICS

1. Medical Record Extraction

2. Adverse Events Case Processing

3. CIOMS Line Listing

4. Case processing and FDA Reporting for Medical Devices

5. Revision of SOP Quality Control Procedure

6. SAE Reconciliation

7. PSUR – Periodic Safety Update Reporting

8. Triage

9. Data Entry

10. Signal Detection

11. Labeling Edit check

12. Quality Control Procedure

13. Resolution of queries of pending cases

14. SUSAR – Suspected Unexpected Serious Adverse Reaction

ADDITIONAL ADVANCED DRUG SAFETY TOPICS

1. Introduction to MedDRA

2. MedDRA Coding Guidelines- Modules 1 thru 4

3. AE Causality assessments

4. Introduction to Risk Management Plan (RMP)

5. Introduction to Risk Management Plan (REMS)

6. Argus Safety End-User Training Modules 1 thru 6

7. Product Technical / Quality Complaints (PTC / PQC)

8. Corrective and Preventative Actions (CAPAs)

9. Overview of Aggregate Reporting (PSUR/ PBRER)

10. Overview of Aggregate Reporting – PRAC / DSUR


The EXERCISES covered in the DSPM training program are:

1. Medical Record Extraction.

2. Adverse Events Case Processing

3. CIOMS Line Listing

4. Case processing and FDA Reporting for Medical Devices

5. Revision of SOP

6. Quality Control Procedure

7. SAE Reconciliation

8. Triage

9. Data Entry

10. Signal Detection

11. Labeling Edit check

12. Quality Control Procedure

13. Resolution of queries of pending cases

14. SUSAR – Suspected Unexpected Serious Adverse Reaction

  • The program gave me an in-depth understanding of the role of a DSA in the Clinical Research and Pharmacovigilance department. With the practical examples and lectures from professionals, I gained a clear understanding of the practical applications needed for work. Very good course work!

    Ramya I (New Jersey)

  • The best part about DSA training is presentations which clearly mention the important and key points that are helpful for building basics in the subject. I found the exercises helpful in understanding the format on how to fill the forms and analyzing the data which will be useful in real-time for me.

    Kinjal C (Virginia)

  • I am a Medical Science graduate. This Certificate training helped me to understand the Job-related work process better. The Drug Safety Associate training program offered at Qtech is very useful for beginners, I liked it and highly recommend others. Currently, I am enrolled into an Internship program to meet my career goals.

    Latha T. (New Jersey

  • Category:
    Drug Safety
  • Duration:
    12 Weeks
  • Price:
    $2,519.00 (USD)
  • Language:
    English